Effects of Chardonnay Seed Flour on Vascular Health

This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).

Study Overview

• Status: Completed
• Conditions: 1. Endothelial Dysfunction (EndoPAT Score <=2)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Chardonnay Seed Flour (CSF)

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >= 18 years old
2. Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening.

Exclusion criteria:

1. Age below 18 or above 80
2. Endothelial function greater than 2.0 at baseline
3. Hypertension (at screening): any patient with systolic blood pressure (SBP >=170 mmHg or diastolic blood pressure >= 110 mmHg, or hypotension (SBP < 100 mmHg
4. Abnormal liver function tests
5. Uncontrolled Diabetes Mellitus or the use of metformin for Diabetes Mellitus
6. Difficulty swallowing capsules
7. Gastrointestinal disease manifesting with symptoms of malabsorption such as celiac disease or Crohn's disease
8. Non-English speakers
9. Vulnerable populations unable to consent such as prisoners or dependents

10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the CSF including, but not limited to, any of the following:

    1. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
    2. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
    3. Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
11. History of hypersensitivity to any of the study supplement or suspected contraindications to the study supplement.
12. History of noncompliance to medical regimens or unwillingness to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chardonnay Seed Flour (CSF); Prepackaged capsules taken 3 times per day. During the first month, the total dose will be 15 g/d. For months 2-4, the total dose will be 30 g/d.	Dietary supplement: Chardonnay Seed Flour (CSF); CSF is made from wine grape skins and seeds.
Placebo Comparator: Placebo; Pre-packaged capsules taken 3 times per day. For the first month, a total of 15 g/d. During months 2 - 4, a total of 30 g/d.	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function as measured by reactive hyperemia EndoPAT scores	Endothelial function (Endothelial Peripheral Arterial Tonometry - EndoPAT) Testing will generate a score at baseline that will be compared to a second EndoPAT test which will be conducted again after the study subjects have taken the study product for 4 months. These scores will be used to determine if the study product had an effect on endothelial function.	Baseline to 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in High Sensitive C-reactive protein (hsCRP)	Baseline to 4 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Whole Vine Products

Publications and helpful links

General Publications

• Corban MT, Widmer RJ, Cilluffo R, Kazeck MA, Lennon RJ, Lerman LO, Lerman A. The effect of polyphenol-rich chardonnay seed supplements on peripheral endothelial function. Eur J Nutr. 2020 Dec;59(8):3723-3734. doi: 10.1007/s00394-020-02203-6. Epub 2020 Feb 17.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 23, 2017

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Endothelial function
• Other Study ID Numbers: 13-007023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No